Ubrogepant for Pediatric Migraine

(Ubro Peds Trial)

Recruiting at 142 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must not be taking: Opioids, Barbiturates, Triptans, others

Disqualifiers: Chronic migraine, Psychiatric conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

1059 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of ubrogepant for treating migraines in children and teens. Ubrogepant is already used by adults for sudden migraine attacks, and this study will determine its efficacy for younger individuals. Participants will be divided into groups to receive different doses of the medication or a placebo (a pill without active ingredients) for comparison. Children and teens who frequently experience intense headaches lasting several hours and have tried other migraine treatments may be suitable candidates for this study. Participants must visit a clinic regularly and complete several assessments over about six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for migraines in younger populations.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking any medication that is on the list of prohibited medications, you may need to discontinue or switch to an alternative medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that adults generally tolerate ubrogepant well. In studies with adults, the most common side effects included nausea, sleepiness, and dry mouth, which were mostly mild.

However, ubrogepant's safety and effectiveness for children remain unconfirmed. This trial aims to determine that. Since the trial is in an advanced stage, earlier research suggests the treatment is likely safe enough for broader testing. Additionally, ubrogepant's approval for adults indicates some level of safety in humans, but more information is needed specifically for children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Ubrogepant is unique because it targets the migraine pathway in a way that's different from traditional treatments like triptans or NSAIDs. Unlike these standard options that often focus on blood vessel constriction or inflammation reduction, ubrogepant works by blocking the CGRP receptor, a key player in migraine development. This mechanism not only offers a new approach to treatment but also reduces some common side effects associated with other migraine medications. Researchers are excited about ubrogepant because it provides an alternative for those who may not tolerate or respond well to existing therapies.

What evidence suggests that ubrogepant could be an effective treatment for pediatric migraine?

Research shows that ubrogepant effectively treats migraines. Studies have found that it significantly reduces pain and other symptoms during a migraine attack. In adults, ubrogepant relieved migraine pain and improved well-being within two hours of administration. Its approval for adult use provides strong evidence of its efficacy. This trial will evaluate ubrogepant in children and teenagers, testing low and high doses, along with a placebo, to determine its effectiveness in younger patients. ^{2 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 6-17 with a history of migraines, experiencing 1-14 attacks per month. They must have tried at least one oral migraine medication and their migraines should last between 3-72 hours if untreated. Exclusions include drug abuse, certain gastrointestinal conditions, specific types of migraines like hemiplegic or retinal, significant neurological disorders other than migraine, frequent hospital treatments for migraines, suicide risk, hypersensitivity to CGRP receptor antagonists or any study components.

Inclusion Criteria

I have tried at least one over-the-counter oral medication for my child's migraines.

My child has had migraines for at least 6 months.

My child experiences 1-14 migraine attacks monthly.

Exclusion Criteria

I can swallow pills or can learn to do so.

I have had 1 to 14 moderate to severe migraines each month for the last 2 months.

You have expressed thoughts of hurting yourself or others in the past 6 months, or have attempted to hurt yourself in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral tablets of ubrogepant or placebo for qualifying migraine attacks, with an option for a second dose or rescue medication

Up to 6 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medical assessments, blood tests, and questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo-Matching Ubrogepant
• Ubrogepant

Trial Overview The trial tests the safety and effectiveness of Ubrogepant—an approved adult migraine treatment—in young patients during acute migraine episodes. Participants will be split into two age groups (6-11 and 12-17) and randomly assigned to receive either a low or high dose of Ubrogepant or a placebo in a double-blind manner. There's a chance they'll get the placebo instead of the actual drug.

How Is the Trial Designed?

Group I: PK Cohort: Ubrogepant Dose B Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group II: PK Cohort: Ubrogepant Dose A Experimental Treatment 1 Intervention

Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.

Group III: Main Study: Children Ubrogepant Low Dose Experimental Treatment 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group IV: Main Study: Children Ubrogepant High Dose Experimental Treatment 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group V: Main Study: Adolescents Ubrogepant Low Dose Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VI: Main Study: Adolescents Ubrogepant High Dose Experimental Treatment 1 Intervention

Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VII: Main Study: Children Ubrogepant Placebo Placebo Group 1 Intervention

Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Group VIII: Main Study: Adolescents Ubrogepant Placebo Placebo Group 1 Intervention

Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.

Ubrogepant is already approved in United States for the following indications:

Approved in United States as Ubrogepant for:

• Acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Ubrogepant, a calcitonin gene-related peptide receptor antagonist, has been shown to be significantly more effective than placebo in providing relief from migraine pain within 2 hours, with odds ratios indicating strong efficacy at both 50 mg and 100 mg doses.

This medication is a safe and effective alternative for patients who cannot tolerate traditional migraine treatments like NSAIDs or triptans, making it an important option for those with limited treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: An Oral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist for Abortive Migraine Treatment. Nedd, M., Garland, S., Falk, N., et al.[2022]

Ubrogepant significantly improves pain freedom and reduces bothersome migraine symptoms within 2 hours compared to placebo, with 20.8% of patients achieving pain freedom versus 12.6% for placebo in a meta-analysis of three trials involving 3326 patients.

Short-term use of ubrogepant does not increase the risk of treatment-related adverse events compared to placebo, indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ubrogepant for the Acute Treatment of Episodic Migraine: A Meta-Analysis of Randomized Clinical Trials. Yang, Y., Chen, M., Sun, Y., et al.[2021]

In a pooled analysis of 2240 participants from two phase 3 trials, ubrogepant 50 mg demonstrated significant efficacy in achieving pain freedom at 2 hours post-dose, with 20.5% of participants reporting this compared to 13.0% in the placebo group (P < 0.001).

Ubrogepant also showed a favorable safety profile, with similar rates of adverse events (11.5% for placebo vs. 11.2% for ubrogepant), and no serious adverse events related to treatment were reported, indicating it is a well-tolerated option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Hutchinson, S., Dodick, DW., Treppendahl, C., et al.[2023]

In a pooled analysis of 2,247 participants from the ACHIEVE I and II trials, ubrogepant demonstrated similar efficacy in treating acute migraine regardless of whether participants were using preventive medications, indicating it is effective for both groups.

The safety profile of ubrogepant was also consistent, with no significant differences in treatment-emergent adverse events between those on preventive treatments and those not, suggesting it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Blumenfeld, AM., Knievel, K., Manack Adams, A., et al.[2022]

Ubrogepant, a CGRP receptor antagonist approved by the FDA, has been shown to be effective in providing pain relief from migraines, outperforming placebo in Phase III trials (ACHIEVE I and II) within 2 hours of administration.

The 52-week open label extension of these trials confirmed the safety of ubrogepant, although a real-world study indicated higher adverse event rates, highlighting the need for further research on its long-term safety and efficacy, especially when used with other CGRP therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant in the Acute Management of Migraine: A Narrative Review. Chiang, CC., VanderPluym, JH.[2021]

A comprehensive analysis of 2,067 reports from the FDA Adverse Event Reporting System revealed that Ubrogepant, used for treating acute migraines, is associated with various adverse events, including nausea, dizziness, and new reports of hemiparesis and mental impairment.

The study highlights the importance of monitoring Ubrogepant's long-term safety, as it identified new adverse events not previously documented in clinical trials, enhancing our understanding of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system. Cao, B., Gu, S., Shen, Z., et al.[2023]

In a Phase 3 clinical trial involving 1686 participants, ubrogepant demonstrated significantly greater efficacy than placebo for acute migraine treatment, with 21.8% of patients achieving pain freedom at 2 hours after taking the 50 mg dose.

Ubrogepant 50 mg also resulted in a higher rate of absence of the most bothersome migraine-associated symptom compared to placebo, indicating its potential effectiveness in alleviating multiple aspects of migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. Lipton, RB., Dodick, DW., Ailani, J., et al.[2021]

In a 52-week trial involving 1230 participants, ubrogepant (50 mg and 100 mg) was found to be safe and well-tolerated for the acute treatment of migraines, with low rates of treatment-related adverse events (10% for 50 mg and 11% for 100 mg).

The most common side effect was upper respiratory tract infection, and there were no serious liver-related issues, indicating that ubrogepant does not significantly impact liver function, which is crucial for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. Ailani, J., Lipton, RB., Hutchinson, S., et al.[2021]

Ubrogepant (Ubrelvy™) is a highly-selective CGRP antagonist that was approved in December 2019 for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

As an orally administered medication, ubrogepant offers a new option for adults suffering from migraines, providing a targeted mechanism of action that specifically blocks the CGRP pathway involved in migraine attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant: First Approval. Scott, LJ.[2020]

In a phase 3 trial involving 518 participants, ubrogepant 100 mg significantly reduced the occurrence of moderate or severe headaches when taken during the prodrome phase of a migraine, with 46% of treated events showing improvement compared to 29% with placebo (p<0.0001).

Ubrogepant was found to be well tolerated, with a slightly higher incidence of adverse events (17%) compared to placebo (12%), indicating it is a safe option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Dodick, DW., Goadsby, PJ., Schwedt, TJ., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05125302

NCT05125302 | Study to Assess Adverse Events and ... The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10693258/

A Comprehensive Review of the Mechanism, Efficacy, Safety ... Ubrogepant offers significant potential for pain relief, symptom reduction, and restoration of normal function during a migraine attack, and it ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9031827/

Emerging Pharmacological Treatments for Migraine in the ... There is evidence to support the efficacy of the use of ibuprofen, acetaminophen (in children and adolescents), and triptans (mainly in ...

4. nature.com nature.com/articles/s41591-025-03679-7

Ubrogepant for the treatment of migraine prodromal ... The most common AEs (≥2%) after placebo and ubrogepant administration were nausea (3% versus 5%), fatigue (2% versus 3%), dizziness (3% versus 2 ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1813049

Ubrogepant for the Treatment of Migraine The coprimary efficacy end points were freedom from pain at 2 hours after the initial dose of ubrogepant or placebo and absence of the most ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05125302

NCT05125302 | Study to Assess Adverse Events and ... The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/211765s000lbl.pdf

UBRELVY (ubrogepant) - accessdata.fda.gov UBRELVY is not used to prevent migraine headaches. It is not known if UBRELVY is safe and effective in children. Do not take UBRELVY if you are taking medicines ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/ubrogepant-oral-route/description/drg-20481621

Ubrogepant (oral route) - Side effects & dosage Ubrogepant is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches.